FDA Approves First Blood Test to Detect Concussions

WEDNESDAY, Feb. 14, 2018 — The first blood test to help diagnose a concussion has been approved by the U.S. Food and Drug Administration.

Known as the Banyan Brain Trauma Indicator, it could help reduce the need for CT scans and thus decrease radiation exposure to patients, according to the FDA.

The blood test checks for levels of specific proteins that have been released from the brain into the blood within 12 hours of a head injury. Test results can be available within three to four hours.

The FDA’s approval of the blood test, given Wednesday, was based on a clinical trial that included more than 1,900 adults with suspected concussion. The study compared results from the blood test with those from CT scans.

It found that the blood test predicted evidence of brain tissue damage on a CT scan 97.5 percent of the time. It predicted no evidence of damage on a CT scan 99.6 percent of the time.

The newly approved blood test will “help health care professionals determine the need for a CT scan in patients suspected of having mild traumatic brain injury [concussion],” according to an FDA news release. It could rule out the need for a CT scan in at least one-third of those suspected of having a concussion, the FDA said.

The blood test’s approval “supports the FDA’s Initiative to Reduce Unnecessary Radiation Exposure from Medical Imaging — an effort to ensure that each patient is getting the right imaging exam, at the right time, with the right radiation dose,” Dr. Scott Gottlieb, the FDA commissioner, said in the news release.

The test also “will likely reduce the CT scans performed on patients with concussion each year, potentially saving our health care system the cost of often unnecessary neuroimaging tests,” Gottlieb said.

Both the general public and members of the military stand to benefit, according to the FDA.

“A blood test to aid in concussion evaluation is an important tool for the American public and for our Service Members abroad who need access to quick and accurate tests,” Dr. Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health, said in the news release.